Shire plc (SHPGY,SHP.L) said Saturday that the US Food and Drug Administration has responded to its Adderall XR citizen petition. The FDA's response requires that all abbreviated new drug applications, or ANDAs, have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products.
The FDA also informed Shire that it has approved the ANDA for generic Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.
Shire said it believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Teva and Impax.
While recognizing that there will be multiple dynamics affecting the overall market following the approval of the Actavis generic, Shire continues to believe that it will deliver good, full year 2012 earnings growth.
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